A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma or ocular hypertension.

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Detailed Description

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Pharmacokinetics and Safety

Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

latanoprost

Intervention Type DRUG

latanoprost 0.005% (1.5 ug) will be administered. A single drop of latanoprost 0.005% will be instilled into both eyes by the investigator.

Interventions

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latanoprost

latanoprost 0.005% (1.5 ug) will be administered. A single drop of latanoprost 0.005% will be instilled into both eyes by the investigator.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* This study will enroll pediatric and adult subjects with glaucoma or ocular hypertension receiving treatment with latanoprost in either one or both eyes for at least two weeks.
* The pediatric subjects will be grouped by age (0 to \<3 years, 3 to \<12 years, 12 to 18 years).

Exclusion Criteria

* Ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the screening visit.
* History of ocular trauma or surgery in either eye within 14-days of the screening visit.
* Use of continuous wear contact lenses.

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No